Quality and Regulatory

October 13, 2023October 13, 2023

Empowering Mid-Size Companies: Harnessing the Power of Artwork Management Solutions

One size does not always fit all. While large corporations often have the means to invest in high-end Artwork Management Solutions (AMS), mid-size companies face a unique challenge. They need to find a middle ground between limited budgets and the demand for efficient, compliant processes.

Thankfully, this is not a problem without a solution as there is not only large scale AMS solutions in the market today but also those that cater to the needs of mid-size enterprises.

Navigating Mid-Size Challenges

Mid-size companies encounter a distinct dilemma: how to achieve streamlined packaging design processes without exceeding their financial capacities, and still complying with regulations for quality, control, and even validation. Unlike industry giants, these businesses require a solution that is both powerful and cost-effective, yet equally adept at ensuring quality and compliance.

Harnessing Innovative Solutions

What are the main benefits that solutions such as Twona for mid-size companies offer?

1. Affordability: Mid-size solutions are designed to be budget-friendly without compromising on performance. This enables mid-size companies to optimize operations without straining their financial resources.

2. Scalability: As mid-size companies evolve, their solutions must evolve too. AMS solutions can adapt to new challenges as businesses expand and diversify.

3. Flexibility: Unlike one-size-fits-all solutions, you will find that it is possible to match the unique workflow of your business, ideal for mid-size companies with distinct processes.

4. Compliance Alignment: Even though you’re not a corporate giant, regulations are still pertinent. You should still be able to meet industry standards and compliance requirements, safeguarding your business against costly setbacks.

Realizing Efficiency: The Power in Practice

The benefits of adopting an AMS solution for mid-range companies extend well beyond the fiscal aspect:

1. Time Efficiency: With AMS solutions fine-tuned to your workflow, tasks become streamlined and automated, drastically reducing the time needed for design approvals and collaboration.

2. Error Reduction: Automated workflows and version control mechanisms significantly diminish the risk of errors, ensuring accurate designs are approved for production without unnecessary delays.

3. Collaborative Seamlessness: encompass collaboration features that enable teams to work harmoniously, regardless of geographical separation.

4. Competitive Advantage: In a competitive arena that values efficiency and adaptability, mid-size companies equipped with an AMS can stand tall alongside industry giants.

Embrace the Opportunity: Unleash the Power of an AMS Solution

If you’re a mid-size company aiming to gain a competitive edge in the packaging sphere, don’t underestimate the use of a powerful AMS. Embrace a solution designed to match your ambitions, enhance your efficiency, and usher in a new era of accomplishment, all while keeping your financial landscape in focus. In a world of dynamic solutions, your business deserves nothing less.

Check out our AMS solution www.twonas.com/ams/ and how it can fit your company.

October 6, 2023March 1, 2024

Forget Email Attachments: Modernizing Packaging Approval with Digital Solutions

Picture this scenario: endless email threads, multiple attachments in several emails as the size limit is reached, wrong attachments sent, lots of back-and-forth to explain that the attachment was wrong and here is the correct one, version confusion… If this is your day-to-day, you can see how it is a recipe for delays, miscommunication, and even the occasional oversight that can have far-reaching consequences.

Thankfully, you can stop that chain of inefficiency and elevate packaging approval processes to new heights of effectiveness—using digital solutions that go beyond the limitations of email attachments.

Rephrase

The Drawbacks of Using Email for Approvals

While email has earned its place for business communication, it proves inefficient when managing essential tasks such as approving packaging designs due to several shortcomings:

1. Disconnected Communication: Keeping track of context and accurately recording changes can be tough due to the scattered nature of email threads.

2. Confusion with version management: The presence of multiple attachments with nearly identical names could breed misunderstanding, chiefly when various editions are being scrutinized at the same time.

3. Sluggish replies: Overfilled inboxes or a surge of incoming emails may result in important messages being missed, leading to holdups in the approval process.

4. Ambiguous Responsibility: Figuring out who has examined or greenlit a design at any moment proves difficult, rendering accountability a fizzy concept.

The Digital Leap: What Modern Approvals Demand

Fortunately, there are digital solutions that tackle the challenges of packaging approvals. These solutions offer a range of features that revolutionize the approval process:

1. Collaborative Workspace: Imagine a virtual space where stakeholders can congregate, review designs, provide feedback, and hold discussions—all within a single, organized platform.

2. Version Tracking: A digital system maintains a comprehensive history of design versions, enabling easy comparison and minimizing errors caused by outdated versions.

3. Transparent Approval Paths: Digital solutions allow you to define and visualize approval paths clearly, ensuring designs navigate through the correct channels without bottlenecks.

4. Automated Reminders: Say goodbye to chasing approvals. Automated notifications ensure that reviewers are prompted at the right time, reducing approval cycle times. You can also choose to send manual reminders.

5. Accountability and Audit Trails: Each action is recorded, creating an audit trail that clarifies who did what, when, and why—an essential feature for compliance-driven industries.

The Transformative Impact: Efficiency and Precision Redefined

Do you need to hear about the advantages of using such a digital solution ?

1. Streamlined Workflows: With collaborative workspaces, design reviews become intuitive and streamlined, eliminating the confusion associated with email chains.

2. Rapid Turnaround: Design approvals take less time, enhancing your ability to bring products to market swiftly and seize new opportunities.

3. Improved Accuracy: Version control hiccups and miscommunications become a thing of the past, reducing the chances of errors slipping through the cracks.

4. Compliance : Industries subject to regulations can breathe easier knowing that an accountable, traceable process is in place.

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So, are you ready to leave the era of email attachments behind and embark on a journey towards efficient, compliant, and precise packaging approvals?

If you are, please give a try to our approvals solution and then, contact us to help you implement it for your team.

March 21, 2023

Claves del éxito al afrontar el diseño del packaging de un nuevo cliente

En el mundo del diseño, la creación de plantillas de diseño o templates a partir de ahora, es esencial para el éxito de cualquier proyecto. Un template es un documento o archivo que se utiliza como base para la creación de nuevos diseños o materiales. Pueden ser simples, como una página en blanco con un borde, o pueden ser más complejas, con una estructura detallada que incluye una variedad de elementos y características.

Necesito encontrar todo o casi todo lo que necesito en un mismo lugar, si no pierdo demasiado tiempo en buscar recursos y no en el propio diseño.
Cualquier diseñador

La importancia de crear templates adecuadas para futuros proyectos radica en la eficiencia que proporciona al proceso de diseño. Un template bien diseñado asegura que los diseños sean coherentes y que se mantengan dentro de la marca o la identidad visual de la empresa. Además, permiten que los diseñadores trabajen de manera más rápida y eficiente, reduciendo el tiempo de creación de un diseño y, por lo tanto, maximizar nuestros recursos.

Al crear los templates, es fundamental asegurarse de que su contenido sea apropiado para el proyecto en cuestión. Si no está diseñada específicamente para el proyecto puede generar problemas de coherencia, o peor aún, puede llevar a errores costosos. Por ejemplo, si una empresa tiene un template para un folleto que se utiliza para anunciar un producto específico, pero luego se utiliza para anunciar un producto diferente, el resultado puede ser una confusión entre los clientes potenciales y una pérdida de credibilidad de la marca.

Los documentos de apoyo son la base para un proceso de trabajo eficiente, se debe tener en cuenta que el template no solo debe ser funcional, sino que también debe ser fácil de usar. Los diseñadores que trabajan en el proyecto deben poder entender y utilizarlo de manera efectiva para que puedan trabajar con rapidez y eficiencia. Por lo tanto, es importante que sea claro, intuitivo y fácil de navegar.

Un ejemplo real para producir el packaging de un nuevo cliente por ejemplo en el sector farmacéutico sería de la siguiente manera:

1. Proyecto piloto: es importante que haya un proceso inicial de aprendizaje donde trabajamos con una muestra que debe abarcar gran parte de los tipos de productos y siempre es importante que contenga ejemplos difíciles. No nos interesa aprender implementaciones sencillos para sufrir inevitablemente cuando lleguen productos complejos obviando que no podemos cubrir todas las opciones.
2. Documentación de apoyo: una vez hayamos trabajando y aprendido los productos en la fase inicial es hora de generar los documentos de apoyo necesarios como templates, procedimientos y los checklists pertinentes. Siguiendo con el ejemplo debería haber tantas triadas (procedimiento, template y checklist) como categorías de productos: Envases, prospectos, aluminios, etiquetas, sobres, etc.
3. Formación, uso y mejora constante: es necesario apuntar que dichos documentos deben ser de uso común y dado que son documentos vivos deben estar en continua revisión partiendo de su uso continuo mejorando y simplificando dichos archivos periódicamente. Es muy común que el contenido inicial de dichos documentos sea más extensiva que concentrada por motivos de seguridad y calidad.

Resumiendo, el diseño del packaging tiene muchos detalles que hay que conjugar alineando también agentes externos con detalles técnicos de los fabricantes y excepciones que no encontrarás en ningún documento. La clave esta en tener una fase inicial que nos ayude (piloto), para nutrirnos de archivos de apoyo que nos faciliten el proceso (templates, procedimiento, checklists) para acelerar el diseño del 90% de los productos y así tener tiempo para las excepciones y seguir creciendo.

March 7, 2023

Improving your Artworks Workflow

As an artwork coordinator working for a pharmaceutical company, I oversee the packaging design process from start to finish. It’s a complex process that involves multiple stakeholders and departments: regulatory, supply chain, printing houses, customers (we also do Contract Manufacturing), Quality Assurance, etc. It requires careful coordination to ensure that everything runs smoothly. Over the years, we’ve refined our process to the best of our abilities, but as with any complex system, there’s always room for improvement. We make our process work, but it requires constant emails, reminders and nudges to certain stakeholders to keep everything in check.

When we decided to purchase an Artwork Management System, we agreed to bring in an external workflow and process consultant to help us optimize our packaging design workflow as we intended to digitise our process. At first, I was a bit skeptical. After all, I knew our process inside and out, and I wasn’t sure how an external consultant could provide any value. Our initial plan was to simply move from a manual email based workflow to a digital one. However, after a couple of phone calls regarding the process, we realized that an external set of eyes can sometimes identify issues in your process that you simply cannot see because you’re too close and too busy.

The Consultant

The consultant that came in had extensive experience working with other pharmaceutical companies, not only within brands, but also in CMOs, design agencies, etc. He got us started by going thought our current process, which was drawn on a white board and asking a lot of questions as we went through every stage: who is involved, what information is provided, when, what are the challenges, what happens in this and that scenario, etc. Very quickly he was able to spot a few areas where we could make improvements. There were a couple of key aspects that were particularly interesting where he suggested some changes in the process by analysing and justifying those suggestions. The following was one of the most relevant ones:

Our Process

In the beginning of our process, the Regulatory Department provides the key information related to the change that has to be implemented in the packaging material: a new text, a set of annotated changes due to a change in regulations and anything in between. When this information is received, the Artworks Team checks it and forwards the request to the agency to execute the changes. Later in the process, once the design has been implemented, the Regulatory colleagues check the artwork to make sure it complied with their request for change. The consultant asked: how often does an artwork need to be redone because Regulatory spotted a mistake in the content (not a mistake introduced by the design agency). The answer across my team was consistent…..very frequently. The consultant then made an estimate of the amount of hours involved across all teams between the moment the request is sent by RA and the moment the design is sent back to them for changes. We calculated around 40 to 50 hours of work.

The Suggestions

His suggestion was simple: add a four eye principle on the information provided by Regulatory BEFORE the artwork request is sent to the agency. The objective was to validate the information before those 40 to 50 hours of work were spent on the artwork so that the number of iterations would be reduced. We quickly involved the QA team, who happily agreed to review the data before it was sent to the agency. It was brilliant. A simple suggestion, a nudge to the colleagues in QA and the potential time savings were incredible.

At first, I was a bit intimidated by the prospect of implementing all suggested changes. After all, change can be difficult, especially when you’re dealing with a process that has been in place for years and many stakeholders involved. However, with an open discussions and proper justification of each suggested change, I realized that these changes were all aimed at making our jobs easier and more efficient. By embracing these changes, we could reduce the amount of time and resources we spent on each project and ensure the best possible outcome. Having an external set of eyes also helped align all relevant parties (external people are not afraid of starting difficult conversations).

Over the next few months, we worked closely with the consultant to implement the changes he had suggested. It wasn’t always easy, and there were a few bumps in the road, but overall, the process went smoothly. We saw an consistent improvement in in our process. and our workflow became much more streamlined. We were able to complete projects more quickly and with fewer errors, which made everyone involved in the process much happier.

Looking back, I’m so glad we decided to bring in an external set of eyes to help us optimize our packaging design workflow. I’m excited to see what other improvements we can make in the future, and I’m grateful for the opportunity to work with such a talented consultant.

If you want an external set of eyes on your process, setup a call with us and let’s work together to make your workflow flawless.

March 6, 2023April 13, 2023

Asking vs SOPing.

In today’s fast-paced business world, every second counts, and no one wants to waste time on repetitive tasks. One area where this is especially true is in the supply chain of packaging design processes where not only time matters but reducing risk is a key factor of the process. Frequently, supply chain teams are asked to supply information that is mostly static and unchanging, yet the requests for this information continue to pour in. For every artwork material surely comes an email requesting the same information. In these cases, identifying repetitive tasks and documenting the necessary information can help save time across the supply chain while reducing unnecessary risks related to information processing.

Let’s consider the following example: An artwork coordinator requests information from the supply chain team regarding the technical specifications of serialisation printing. The details provided by the supply chain always relate to the market where the product is going to be released (different market, different rules) and change only every one or two years when the regulatory bodies change the laws. The request for information is done for every product, and therefore the response from the supply chain is almost always the same. Furthermore, supply chain is the only team up to date on when the regulations change.

In this situation, creating a set of technical specifications in the form of a Standard Operating Procedure (SOP) can help streamline the process. The SOP would describe the serialization requirements per market (what information can be printed where and under which technical specifications), and the supply chain team would become the owners of these documents. By creating and documenting these technical specifications, the supply chain team can prevent the information from being requested for every product, thereby saving a tremendous amount of time while reducing the risk of misinformation.

The benefits of creating SOPs and technical documents go beyond time-saving. By documenting and standardizing information, it becomes easier to communicate and collaborate with team members and stakeholders. This standardization can also reduce errors and improve the quality of the work.

Furthermore, the benefits of documenting information go beyond the immediate supply chain team. If the information is needed by other teams, such as quality assurange or regulatory affairs, having a documented SOP can ensure that everyone is on the same page and using the correct information. This can help prevent delays and ensure that all aspects of the product development process are aligned.

In conclusion, identifying repetitive tasks and documenting necessary information can help save time across the entire supply chain of packaging design. The example of creating an SOP for serialization requirements illustrates how this process can be applied in practice on any company that markets products across different countries. By creating and maintaining such documents, teams can save time, reduce the risk of misinformation, and improve the overall quality of their work.

Do you email or do you SOP?

Interested in hearing more?

Click the button below to receive a call, or send us information on what you are looking for to improve Artwork Management. We will be happy to help you!

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February 16, 2023

Accountability and Authority, The Saga

Once upon a time, in a packaging company not so far away, there was a team of designers tasked with the creation and management of product packaging for their Ancestors . The designers were excited to start working on the project and put their creative and technical skills to the test. They had been trained by the master Designers and could summon the Gods of Regulatory.

The Gods of Regulatory were responsible for ensuring that the package met all necessary regulations and guidelines, Lord praise the FDA, the EMA and the local regulatory bodies. They were accountable for the content that was placed on the packaging design. And they were good at it. They had to appease the recall demons, for one mistake could cost them dearly.

After many times together in the battle field however, the Designes and the Gods of Regulatory realized that while they were accountable for the packaging, and would suffer the consequences of an attack on their impeccable recall record, they lacked the authority to make any meaningful changes on their battle process. There were simply too many stakeholders, too many hidden decision makers and way too many KPIs to fulfil.

One day, the designers submitted a proposal for an improved workflow model that they were particularly proud of. They had worked hand in hand with the regulatory team tirelessly on it for weeks and were excited to finally present it to the higher court, the Decision Makers. However, they were swiftly denied their wishes. The Decision Makers had rejected the proposal outright, without providing any concrete reasons for their decision. They simply said: It shall not be done.

The designers were frustrated, the regulatory experts were angry. They all felt like they were being held accountable for something they had no control over. If something went wrong, their heads would roll, but without the means to change course, they felt abandoned and desperate. They began to lose their faith, their motivation and engagement in the project. To make matters worse, they soon discovered that the same thing was happening to other teams in the company.

The problem wasn’t just with their process; the company’s organizational structure and old fashioned culture made it difficult for anyone to have the necessary authority to make meaningful changes. Everything had to be escalated to the high court, where decisions were made without hands-on knowledge of the actual work that had to be done.

As a result, the frustrated designers and regulatory experts decided to take matters into their own hands. They started taking actions outside of their workflow to expedite the pressing deadlines and reach their tight objectives. They were operating under the blanket of cover and darkness, very much aware of the lack of compliance and added risks. But they had no choice, it was the only way to complete the assigned tasks.

The moral of the story is that accountability without authority can be a frustrating and demotivating experience. Furthermore, when the processes in place do not match the actual job requirements, the non-authoritative stakeholders are usually forced to take action, stepping outside of the agreed models to accomplish their tasks. When key stakeholders lack the necessary authority to make changes, it can lead to a lack of engagement and creativity, and in most cases non-compliance with SOPs. In the case of packaging companies, designers and regulatory experts must work together to ensure that the design process is collaborative and efficient, but they need to have authority to make changes to the process when it no longer works.

Do you feel accountable but lack authority?

February 14, 2023

5 key components of a VMP for SaaS

Artwork management in the pharmaceutical industry is a critical process that requires accuracy and precision to ensure compliance with regulatory requirements and avoid errors in the packaging design that make it to the market and risk a product recall. The artwork management process is sometimes underestimated as it pertains to a non-core activity for brands and manufacturers of medicines and medical devices. However, it can be a critical aspect when facing an audit and even more when such audit is triggered by a product recall.

Multi-tenant SaaS solutions are becoming more popular with pharmaceutical companies, despite the traditional on-site installations, as they offer lower pricing points and less on-boarding hassle (lower financial costs and faster implementation). One key component that is still not fully understood is the fact that validation of on-site custom made solutions differs significantly from the validation approach required for multi-tenant SaaS applications.

The first key component is the Validation Master Plan (VMP) which outlines the validation process. Here we will discuss five key components that must be included in a VMP document for the validation of a multi-tenant SaaS Artwork Management System.

Scope and Objectives – This section needs to clearly define the scope and objectives of the validation process. Let’s dive in. The scope should outline the functionalities of the multi-tenant SaaS solution that will be validated, including any third-party integrations. It is important to define the scope with care and discuss which components need to be included. One aspect that is often overlooked when validation a SaaS application is that in many cases, there will be external services (typically micro services) and infrastructure. These, as long as they only play a servicing role, can be left out of the scope since they are controlled by a third party. The objectives should detail the specific outcomes that the validation process aims to achieve, such as ensuring compliance with regulatory requirements or minimizing the risk of errors or data loss.
Validation Strategy and Acceptance Criteria – The validation strategy should specify the validation approach, including the type of validation to be performed, such as installation qualification, operational qualification, and performance qualification. It is a good idea to include specifically which aspects of the solution will be relevant for the validation. The acceptance criteria should detail the testing methodology, including the type of testing to be performed, such as functional testing, user acceptance testing, and performance testing.
Roles and Responsibilities – This section should clearly outline the roles of the validation team, project manager, system administrator, and any other key stakeholders involved in the validation process. It should also detail the responsibilities of each team member, including their participation in the validation activities and their expected deliverables.
Testing Documentation – The documentation section should detail the testing documentation that will be used and delivered during the validation process. This section should include a list of all required testing documents, including test plans, test scripts, and test cases. It can also outline the testing schedule and the expected timeline for completing each testing activity.
Change Control – The final component of a VMP document should detail the procedures for making changes to the multi-tenant SaaS solution after the validation process is complete. It should include a list of change control forms (or other methods for documenting the required changes), detailing the requirements for documenting changes, and the process for reviewing and approving changes.

The VMP document is an essential tool that will guide you through the validation process.There is however not a single way to create it. Depending on your scope and criteria, the contents of the document can change dramatically. One critical aspect is choosing carefully which components of the application you are going to validate. For applications that rely on external infrastructure or services, specially when managed by third parties, it might prove difficult to get all the components required to validate those services. Our advice is to focus on your application and ensure that all third party infrastrucure and services are only services and do not represent a core data processing unit of your set of features.

If you get the VMP right, the rest of the validation will be much more approachable than having to come back to the VMP to make changes. Spend your time wisely, get the VMP right and your validation will be a breeze.

Want to know more key differences between a traditional VMP and a VMP for a SaaS solution, let us know!

February 13, 2023

Version 1.1….version 1.1_new….version 1.1_final

Document versioning is an essential aspect of packaging design, as it ensures the accurate tracking of changes made to the design from one iteration to the next. If you have ever received or sent an email with a subject or a filename that reads something along the lines of “Version 3_final_final”, then keep reading.

Version Control

Version control is the first aspect of document versioning in packaging design. It involves keeping track of all changes made to the design, including modifications to text, graphics, and other elements. This helps ensure that all stakeholders can identify the latest version of the design, reducing the risk of confusion and errors. When I say identify, I mean it. It is not just about downloading the right version, but about being able to uniquely identity a file by just looking at it.

By using version control (keep on reading, we get to the main course soon), the complete creation and modification process is properly tracked. This is particularly critical in highly regulated environments such as packaging design for pharmaceutical companies.

Version Numbering

Version numbering involves assigning a unique version number to each iteration of the design. It is not really relevant HOW the number is defined. Some companies prefer to use a combination of numbers and letters (Version 1 revision A, Version 1 revision B), while others prefer a more straightforward model based on integers (Version 1, Version 2). We do prefer a mixed approach with 2 versioning digits: Version.Subversion. This allows us to track easily major revisions with the first digit and feedback rounds with the second (1.1, 1.2, 2.1, 2.2). The version number NEEDS to be included in the design itself in a way that can be printed. This allows port print identification of design versions which will be critical in the event of a product recall or an audit.

By using version numbering, designers can easily identify which version of the design they are working on, reducing the risk of errors and ensuring that everyone is working with the same version. This also helps with traceability, as the version number can be used to track changes and identify the origin of any issues that may arise.

Version History

It is also important to keep a record of all changes made to the design, including who made the change, when it was made, and why it was made. The link between the version history and the design itself is made via the version number. For every version number, there has to be a historic record of changes and change requests. If you rely on emails, papers or phone calls for this…..you should read this.

Version history is critical at the Quality Control stage or the workflow when someone needs to validate that the changes made are what was expected and nothing else was introduced by mistake.

I don’t wanna

Many teams are reluctant to implement a printable version control system. This can be due to fear of being perceived as a team that needs more than one iteration to get it right. However, when multiple version 1s exist on a given system (email, shared folders, wetransfer) the risk of printing the wrong file becomes a very serious concern. No auditor in its right mind would ever pass a packaging company that does not implement version control from conception to printing.

February 10, 2023February 10, 2023

Por qué exigir documentos técnicos correctos para el diseño de tu packaging

A la hora de diseñar un packaging hay tres pilares fundamentales:

Guideline donde se describen las reglas corporativas respecto, colores, proporciones, posición de elementos y logos, en definitiva la esencia de nuestra organización.

Los textos a implementar, generalmente un documento word idílicamente revisado por el departamentos de asuntos regulatorios o marketing según el tipo de producto.

El documento técnico aportado por el fabricante o impresor donde se definen las medidas, tipo de material, grosor y reglas en códigos visuales.

Centrándonos en el documento técnico, en primera instancia no debería ser un problema dado que el impresor, debería aportar un documento con sus reglas para que el diseñador implemente los textos necesarios con la esencia del cliente.

Cuando me preguntan que hago en mi trabajo me gusta decir que hago puzzles, y para ello las piezas deben encajar, ¿verdad?.

Cómo debe ser un documento técnico

Los detalles en estos documentos son esenciales para garantizar que el diseño y la producción del envase se realicen de manera eficiente y efectiva. Después de más de 20 años produciendo packaging con miles de modelos el proceso se puede hacer tan complicado como poco claro sean sus reglas además de las muy comunes omisiones de información por lo que básicamente debe incluir solamente cinco detalles bien definidos, sólo cinco:

1.- Escala 1:1, es decir, una escala correcta sin proporciones incoherentes. Del mismo modo ya se ven poco, pero no hace mucho podías encontrar planos hechos con el famoso Autocad con diseños mal escalados e inservibles para su uso y edición en herramientas básicas de diseño como Illustrator o Indesign.

2.- Especificaciones respecto al material, incluyendo gramaje, grosor, si es un material reciclado y siendo exquisito una ayuda visual para sabes si es un papel continuo en rollo o si es tipo cliché entre.

3.- Límites y máximos, donde debe especificarse detalles como los márgenes, zonas de impresión o por el contrario zonas libres de texto donde no debemos incluir información dado que dicha zona tiene una reserva para incluir los datos variables o es una zona de plegado, por ejemplo. Otros detalles serían la posición del braille, localización de las etiquetas para garantizar la inviolabilidad, los datos variables como loteado o fecha de caducidad y posición de los datos de la famosa serialización.

4.- Reglas respecto a los códigos visuales, en éste apartado hay mucha variedad como laetus, códigos 128, datamatrix, collating marks (perdón, no conozco la acepción en español). En cualquier caso todos estarán bien definidos si se define: posición, orientación, dimensión y color.

5.- Colores, definiendo aspectos como el máximo de colores posibles, especificar si debe tener un color específico como negro muy común en un prospecto. La excelencia en éste apartado sería tener una nomenclatura de los colores técnicos, es decir, lo contrario a recibir un documento en cuatricomía (CMYK). ¿Es mucho pedir un documento con colores bien estructurados?. Si recibes de tu impresor un documento técnico con colores con una nomenclatura como la siguiente: dimensions, cutting, creasing, guides, perforating, Text Area, Text Free, Ink Free, solo me queda aconsejarte que felicites a tu impresor y que sigas trabajando con él todo lo que puedas.

Para terminar, exige a tu impresor que cumpla con éstas cinco pautas, la excelencia esta en la búsqueda de la mejora continua, de ésta manera te vas a ahorrar mucha frustración cuando te llegan una y otra vez rechazos de tus materiales incurriendo en versiones innecesarias y los nunca deseados retrasos sin mencionar la gran importancia si hablamos de nuevos lanzamientos.

February 8, 2023

The truth and nothing but the truth

Having a single source of truth is a key aspect of effective design management, particularly when it comes to packaging materials and more so in highly regulated environments where a recall is akin to….well….the devil. When multiple stakeholders play a key role, it’s essential to have a clear and centralized system for managing the design process to ensure consistency, accuracy, and efficiency.

Centralised Source of Truth

A centralized source of truth refers to a single, authoritative repository of information or data that serves as the authoritative reference for all stakeholders involved in a project. In the context of managing design files, a centralized source of truth refers to a centralized system or platform where all design files, specifications, and other relevant information are stored, managed, and updated. This system serves as the authoritative reference for all stakeholders involved in the design process, including designers, regulatory affairs specialists, quality managers, marketers, printers, production specialists and other decision-makers.

The purpose of having a centralized source of truth is to ensure that everyone involved in the project is working with the same information and that everyone has access to the latest version of the design files. This helps eliminate confusion and miscommunication and ensures that everyone is working towards the same goal.

A centralized source of truth also makes it easier to track changes and maintain version control. All updates and changes to the design files are made in one place, making it easier to keep track of who made changes and when. This helps reduce the risk of errors and inconsistencies and ensures that everyone is working with the latest version of the design files.

Three key aspects

Here are three of the most important aspects of having a single source of truth in this context.

Collaboration and Coordination: Having a single source of truth makes it easier for all stakeholders to collaborate and coordinate on the design process. Instead of having multiple versions floating around in different folders or email attachments, everyone has access to the same information, making it easier to track changes, communicate with each other, and ensure everyone is working in sync.
Version Control: In a decentralized system, it can be challenging to keep track of which version of the design is the most recent and accurate (have you ever seen version 1, version 1_new, version 1_new_new? kind of thing). This can result in errors and inconsistencies in the final product. Having a single source of truth allows for accurate and safe version control and ensures that everyone is working with the latest information.
Traceability and Auditability: Having a centralized and well-organized system for managing the design process helps ensure that all decisions are properly documented and can be traced back to the original source. This is important for ensuring accountability and maintaining a clear record of the design process. In the event of a problem, it’s much easier to determine who made a decision and why, which can help minimize the risk of costly mistakes and protect the company from liability. If you work under highly regulated agencies (pharma, food, etc) this is not even a nice to have, but an absolute must. If you are managing files using sharepoint or local folders…..God had mercy on your soul if you ever have to undergo an audit.

Risky Business

The biggest risk of not having a single source of truth and relying on shared folders or decentralized systems is the potential for a failed design to make it to the market. This can result in negative consequences for the company, such as lost sales, decreased brand reputation, and increased costs for correcting the problem. Bonus risks and costs if you are dealing with a pharmaceutical product that can kill a patient. Having a centralized and well-organized system in place helps minimize this risk by ensuring that everyone is working with the same information and that the design process is properly documented and auditable.

If you are still working with Excel files and local folders….well…..I mean…..its 2023…..you don’t have to do that anymore.